510(k) K024160
- Device
- NEOSPORIN SCAR SOLUTION
- Applicant
- WARNER-LAMBERT CO.
- 510(k) number
- K024160
- Product code
- MDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-03-17
- Date received
- 2002-12-17
- Regulation
- 878.4025
- Classification name
- Elastomer, Silicone, For Scar Management
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN R JACOBS
- Address
- 201 Tabor Rd. Morris Plains NJ US 07950 07950
FDA Registration Numbers#
- 9616572
- 2031444
- 3019769561
- 3009317711
- 3012421607
- 3015414875
- 3013530949
- 3003828812
- 3030446844
- 3009192857
- 1000119796
- 3030234167
- 2182979
- 3009655869
- 3045058049
- 3003866267
- 3023855650
- 3012084379
- 3038624837
- 3044026004
- 3012979524
- 3025413691
- 3008693666
- 3010401517
- 2431069
- 8022978
- 3016585381
- 1062964
- 3013530901
- 3043226252
- 3016758972
- 3008242042
- 3014982332
- 3031184338
- 3004967086
- 3005621808
- 3030746897
- 3030067857
- 3012314549
- 3031582449
- 2028924
- 3022754162
- 3038310422
- 3016426851
- 3007257878
- 3003348807
- 3036497112
- 3017036472
- 1000524645
- 3008951066
- 3007607706
- 3010822231
- 1526072
- 3015937050
- 3023662442
- 8023033
- 3019315696
- 3007648359
- 3026331889
- 3038222326
- 3009843176
- 3010034367
- 3012852163
- 2022548
- 3025430795
- 3005488444
- 3010700223
- 3042261316
- 1038758
- 3005630901
- 3015277818
- 3023141635
- 3021090069
- 3009548473
- 3027344214
- 3010957766
- 3038356900
- 3019867040
- 3010160370
- 3025430561
Source Documents#
Other 510(k) Records For Product Code MDA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K112131 | NEODYNE DRESSING | Neodyne Biosciences, Inc. | 2011-09-29 |
| K111733 | CORELEADER SCAR-DIMMER | Coreleader Biotech Co., Ltd. | 2011-09-22 |
| K083718 | BEAU RX SCAR CARE GEL | Beau RX Solutions, LLC | 2009-01-26 |
| K053481 | KELO-COTE SPRAY | Advanced Bio-Technologies, Inc. | 2006-04-14 |
| K041704 | NEWGEL AND NEWGEL PLUS E | Newmedical Technology, Inc. | 2005-10-17 |
| K040307 | HANSON SCAR ADE | Hanson Medical, Inc. | 2004-08-12 |
| K024057 | CURAD SCAR THERAPY | Beiersdorf, Inc. | 2003-06-18 |
| K023678 | DIMISIL SCAR GEL | Aesthetic and Reconstructive Technologies, Inc. | 2003-01-23 |
| K023136 | OLEEVA FABRIC | Bio Med Sciences, Inc. | 2002-10-16 |
| K014036 | MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. | Medtrade Products , Ltd. | 2002-02-14 |
| K013732 | GELZONE | Implantech Associates, Inc. | 2002-02-07 |
| K012419 | CONFORM SHEETING, MODEL IGEL | Implantech Associates, Inc. | 2001-10-24 |
| K010675 | ENSIL FABRIC | Gottfried Medical, Inc. | 2001-05-30 |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | Advanced Medical Solutions, Ltd. | 2001-04-25 |
| K003979 | MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD | Medtrade Products , Ltd. | 2001-03-19 |
Legacy Summary#
summary
FDA Review#
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